RecruitingPhase 2NCT03804944

Converting HR+ Breast Cancer Into an Individualized Vaccine

Sponsor

Weill Medical College of Cornell University

Enrollment

100 participants

Start Date

Mar 17, 2020

Study Type

INTERVENTIONAL

Conditions

Breast Cancer

Summary

Newly diagnosed post-menopausal women with clinical stage II-III, HR+HER2- breast cancer are eligible to a randomized trial, concurrently open at five US academic institutions. Patients receiving 4 months of standard neoadjuvant hormonal therapy with letrozole are randomly assigned to one of 4 arms of a trial testing focal hypo-fractionated RT alone or with immunotherapy combinations.

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 90 Years

Plain Language Summary

Simplified for easier understanding

This trial is investigating whether hormone receptor-positive (HR+) breast cancer tumors can be transformed into a personalized vaccine by treating the tumor with specific drugs before surgery, which may help train the immune system to fight the cancer. **You may be eligible if...** - You are a woman aged 18 or older who has gone through menopause - You have been diagnosed with a specific type of breast cancer that is hormone-receptor positive (ER+ and/or PR+) and HER2-negative - Your breast cancer is early to locally advanced stage (Stage I to III) - Your blood counts and liver function are within acceptable levels - You are in generally good health (able to carry out normal daily activities) **You may NOT be eligible if...** - You have not yet gone through menopause - Your cancer is HER2-positive - You have another type of breast cancer not meeting the above criteria - Your overall health status makes participation unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONFocal Radiation therapy

Focal hypo-fractionated radiation therapy 8 Gy x 3 fractions, starting day 8, every other day (M/W/F or W/F/M or F/M/W).

DRUGPembrolizumab (200mg IV for 30 minutes

Pembrolizumab, on day 12 (last day of radiotherapy), infused over 200mg IV over 30 minutes and then repeated every 3 weeks until disease progression or unacceptable toxicity.

BIOLOGICALCDX-301

Ftl-3 ligand, self-administered by subcutaneous injections at week 1, daily, for 5 consecutive days.